Craniosynostosis
Conditions
Keywords
Pleth Variability Index, Perfusion Index, Craniosynostosis Surgery, Pediatric Anesthesia, Hemodynamic Monitoring, Intraoperative Hemodynamics, Fluid Management
Brief summary
This prospective observational study aims to evaluate the role of pleth variability index (PVI) and perfusion index (PI) monitoring in intraoperative hemodynamic control among pediatric patients undergoing craniosynostosis surgery. Patients aged 0-6 years will be monitored intraoperatively using standard anesthesia monitoring together with PVI and PI measurements. Hemodynamic parameters, including systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, blood loss, fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be recorded. The study will assess the association between PVI/PI changes and intraoperative hemodynamic status, bleeding and transfusion requirements.
Detailed description
Craniosynostosis surgery in pediatric patients is associated with a high risk of intraoperative blood loss and hemodynamic instability. Because children have a relatively low circulating blood volume, early detection of intravascular volume changes is essential for maintaining adequate perfusion and preventing hypotension. Goal-directed fluid management may improve oxygen delivery and overall hemodynamic stability during major surgical procedures. Pleth variability index (PVI) is a noninvasive dynamic parameter derived from pulse oximetry waveform analysis and reflects respiratory variations in the perfusion index (PI). PI and PVI may provide useful information regarding peripheral perfusion, volume status and fluid responsiveness during mechanical ventilation. However, data regarding the utility of these parameters in pediatric craniosynostosis surgery are limited. In this prospective observational study, pediatric patients aged 0-6 years undergoing craniosynostosis surgery will be followed intraoperatively. PVI and PI values will be recorded at predefined time points during surgery together with standard hemodynamic and perioperative parameters. Systolic, diastolic and mean arterial pressure, heart rate, central venous pressure, oxygen saturation, body temperature, urine output, estimated blood loss, amount of fluid replacement, blood product requirement, serum lactate level, blood gas parameters and intraoperative complications will be documented. The relationship between PVI/PI measurements and intraoperative hemodynamic changes, bleeding, fluid administration and transfusion requirements will be analyzed.
Interventions
None listed
Sponsors
Muzaffer GENCER
Başakşehir Çam & Sakura City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Inclusion criteria
* Pediatric patients aged 0 to 6 years * Patients scheduled to undergo craniosynostosis surgery * American Society of Anesthesiologists physical status I, II or III * Written informed consent obtained from the parent or legal guardian
Exclusion criteria
* Patients older than 6 years * American Society of Anesthesiologists physical status IV * Inappropriate preoperative fasting status * History of significant cardiac, pulmonary or renal disease * Patients operated at another institution and subsequently transferred to the study center * Patients with peripheral circulatory impairment * Withdrawal of consent by the parent or legal guardian
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Pleth Variability Index and Intraoperative Hemodynamic Parameters | From induction of anesthesia until the end of surgery | The primary outcome is the association between intraoperative pleth variability index (PVI) values and hemodynamic parameters, including systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate and central venous pressure, in pediatric patients undergoing craniosynostosis surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Hemodynamic Complications | From induction of anesthesia until the end of surgery | The incidence of intraoperative hemodynamic complications, including hypotension and clinically significant hemodynamic instability requiring intervention, will be recorded. |
| Association Between Perfusion Index and Intraoperative Hemodynamic Parameters | From induction of anesthesia until the end of surgery | The association between intraoperative perfusion index (PI) values and systolic arterial pressure, diastolic arterial pressure, mean arterial pressure, heart rate, central venous pressure and oxygen saturation will be evaluated. |
| Association of PVI and PI With Intraoperative Blood Loss and Transfusion Requirement | From skin incision until the end of surgery | The relationship between PVI/PI measurements and estimated blood loss, intraoperative fluid replacement and blood product transfusion requirement will be analyzed. |
| Association of PVI and PI With Intraoperative Fluid Replacement | From induction of anesthesia until the end of surgery | The relationship between PVI/PI values and the amount of intraoperative crystalloid, colloid and blood product administration will be evaluated. |
| Association of PVI and PI With Intraoperative Metabolic and Perfusion Parameters | From induction of anesthesia until the end of surgery | The association between PVI/PI measurements and serum lactate level, blood gas pH, base excess, central venous oxygen saturation, urine output and body temperature will be assessed. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMuzaffer Gencer, associate professor
Outcome results
None listed